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Genotropin Treatment in Short Prepubertal Children With Intra-Uterine Growth Retardation

NCT ID: NCT01073605

Last Updated: 2010-11-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

1993-07-31

Study Completion Date

2009-05-31

Brief Summary

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To evaluate the effect of continuous and intermittent administration of Genotonorm on stature in short prepubertal children with intra-uterine growth retardation

Detailed Description

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Conditions

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Growth Disorders Intrauterine Growth Retardation

Keywords

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Short height intra-uterine growth retardation Genotonorm continuous treatment intermittent treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Genotonorm A

Continuous 0.7 IU/kg/week or 0.03 mg/kg/day

Group Type ACTIVE_COMPARATOR

Genotonorm

Intervention Type DRUG

0.7 IU/kg/week or 0.03 mg/kg/day, daily subcutaneous injection

Genotonorm B

Continuous, 1.4 IU/kg/week or 0.06 mg/kg/day

Group Type ACTIVE_COMPARATOR

Genotonorm

Intervention Type DRUG

1.4 IU/kg/week or 0.06 mg/kg/day, daily subcutaneous injection

Genotonorm C

Intermittent, 1.4 IU/kg/week or 0.06 mg/kg/day

Group Type ACTIVE_COMPARATOR

Genotonorm

Intervention Type DRUG

1.4 IU/kg/week or 0.06 mg/kg/day, daily subcutaneous injection Intermittent treatment (6 months with treatment and 6 months without)

Interventions

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Genotonorm

0.7 IU/kg/week or 0.03 mg/kg/day, daily subcutaneous injection

Intervention Type DRUG

Genotonorm

1.4 IU/kg/week or 0.06 mg/kg/day, daily subcutaneous injection

Intervention Type DRUG

Genotonorm

1.4 IU/kg/week or 0.06 mg/kg/day, daily subcutaneous injection Intermittent treatment (6 months with treatment and 6 months without)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Chronological age (CA) between 3 and 10 for girls
* Chronological age between 3 and 12 for boys
* Height for CA below - 2 SD
* Birth length for CA below -2SD

Exclusion Criteria

* Endocrine disease except well-substituted hypothyroidism
* Sever chronic disease
* Skeletal dysplasia
* Known chromosomal aberration
* Ongoing treatment with steroids
* Known intrauterine infection
Minimum Eligible Age

3 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Angers, France, France

Site Status

Pfizer Investigational Site

Grenoble, France, France

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Pfizer Investigational Site

Paris, France, France

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Pfizer Investigational Site

Amiens, , France

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Pfizer Investigational Site

Besançon, , France

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Pfizer Investigational Site

Bordeaux, , France

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Pfizer Investigational Site

Bordeaux, , France

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Pfizer Investigational Site

Boulogne, , France

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Pfizer Investigational Site

Brest, , France

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Pfizer Investigational Site

Bron, , France

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Pfizer Investigational Site

Clermont-Ferrand, , France

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Pfizer Investigational Site

Dijon, , France

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Pfizer Investigational Site

Grenoble, , France

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Pfizer Investigational Site

Hyères, , France

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Pfizer Investigational Site

Lille, , France

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Pfizer Investigational Site

Lille, , France

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Pfizer Investigational Site

Marseille, , France

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Pfizer Investigational Site

Montpellier, , France

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Pfizer Investigational Site

Nantes, , France

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Pfizer Investigational Site

Nice, , France

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Pfizer Investigational Site

Paris, , France

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Paris, , France

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Pfizer Investigational Site

Reims, , France

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Pfizer Investigational Site

Rennes, , France

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Pfizer Investigational Site

Rouen, , France

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Pfizer Investigational Site

Saint-Priest-en-Jarez, , France

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Pfizer Investigational Site

Strasbourg, , France

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Pfizer Investigational Site

Tarbes, , France

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Pfizer Investigational Site

Toulouse, , France

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Pfizer Investigational Site

Tours, , France

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Pfizer Investigational Site

Vandœuvre-lès-Nancy, , France

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Countries

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France

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=93-8122-001&StudyName=Genotropin%20Treatment%20in%20Short%20Prepubertal%20Children%20with%20Intra-Uterine%20Growth%20Retardation

To obtain contact information for a study center near you, click here.

Other Identifiers

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A6281186, CTN 93-8122-001

Identifier Type: -

Identifier Source: secondary_id

93-8122-001

Identifier Type: -

Identifier Source: org_study_id